Arbutus Biopharma Corporation (Nasdaq: ABUS), an industry-leading
Hepatitis B Virus (HBV) therapeutic solutions company, today
reports its first quarter 2019 financial results and provides a
corporate update.
“Arbutus is committed to the development of an
effective combination regimen to achieve an HBV cure. We continue
to believe that the development of a cure for chronic HBV can best
be achieved by employing a combination of therapeutic agents with
complementary mechanisms of action,” said Dr. Mark J. Murray,
President and Chief Executive Officer of Arbutus. “Our pipeline, of
proprietary therapeutic agents that target HBV replication and
HBsAg expression could in combination, lead to a cure. “
Recent Clinical Accomplishments and Key
Corporate Objectives AB-506
- In a Phase 1a/1b clinical trial,
AB-506, Arbutus’ oral capsid inhibitor, successfully progressed
through the healthy volunteer portion and is currently being
administered in two dose levels to HBV patients in the 28-day
multiple dose portion of the trial. Top-line results of an interim
analysis from this Phase 1a/1b clinical trial are expected in July
2019 at which time we expect to disclose information on clinical
safety in healthy volunteers and safety and efficacy data in
chronically infected HBV patients at both dose levels. We intend to
present more detailed information on the trial at an upcoming
scientific conference towards the end of 2019.
- A Phase 2a dose-finding and
long-term safety trial of AB-506 with an approved nucleoside
analogue is planned to initiate late in the second half of the year
to support the use of AB-506 in future combination registration
trials.
AB-729
- AB-729, an RNAi agent which blocks
HBsAg expression that is administered subcutaneously and is
intended to be dosed monthly, has successfully completed
IND-enabling studies in support of the single ascending dosing
portion of a Phase 1a/1b clinical trial which the Company filed as
part of a Clinical Trial Application. On May 3rd, a regulatory
authority requested that the Company complete its ongoing 3- and
6-month toxicology studies before commencing the single ascending
portion of the Phase 1a/1b clinical trial, which was planned for
this quarter. As a result of this request, the clinical trial start
will be delayed. We will explore options to accelerate its
initiation based on the currently available toxicology study
duration and update the market when the clinical trial start date
is fixed.
RNA Destabilizer Program
- Arbutus remains committed to the
development of oral RNA-destabilizers that have shown compelling
anti-viral effects in multiple HBV preclinical models. AB-452,
Arbutus’ lead oral RNA-destabilizer is being evaluated in a series
of in vitro and in vivo studies to further characterize the
compound, its mechanism of action, safety and pharmacokinetic
profile before deciding whether to initiate clinical trials.
Following careful assessment of the nonclinical safety findings
that led to pausing the entry of AB-452 into human clinical
studies, we have concluded that the nonclinical safety study
resulted in several confounding observations which included
clinical observations with no histological correlation, a lack of
dose response regarding some key findings and an unexplained
vehicle effect. Because of these confounding observations, we have
determined that repeating the 90-day preclinical safety study in
two species is appropriate before making a go/no-go decision. We
expect that the results of this study will allow us to make that
decision early in 2020.
- In parallel, the Company is
advancing several follow-on compounds, with distinct chemical
scaffolds, into the lead optimization stage, with a goal of having
a 2nd generation candidate nominated for development by the end of
2019.
Dr. Michael J. Sofia, Arbutus’ Chief Scientific
Officer, stated, “We continue to believe that oral RNA
destabilizers represent a very relevant and important therapeutic
approach to treating HBV. We also believe we continue to have the
most advanced program of this kind in the HBV field and that
success here could be very significant for HBV patients, as well as
for Arbutus.”
Early R&D Programs
- The Company continues a robust
discovery effort focused on follow on compounds for its current
pipeline, including further advancements in the Company’s capsid
inhibitors and RNA destabilizers as well as discovery efforts
focused on reawakening HBV patients’ immune response and novel
HBV-specific targets such as compounds targeting PD-L1 and HBV
cccDNA.
ONPATTRO Royalty
Entitlement
ONPATTRO is an RNAi therapeutic that has been
developed for the treatment of hereditary ATTR (hATTR) amyloidosis,
and has been approved by the FDA and the EMA. Arbutus has a royalty
entitlement on global sales of ONPATTRO for the LNP technology
licensed by Arbutus to Alnylam for this product. The Company began
recognizing royalty income in 2018. The royalty rate is tiered,
based on product sales, and in the low to mid-single digits.
Financial Results
Cash, Cash Equivalents and
Investments
Arbutus had cash, cash equivalents and
short-term investments totaling $110.6 million as of March 31,
2019, as compared to $124.6 million as of December 31, 2018.
The $14.0 million decrease for the three months ended March 31,
2019 was due primarily to $16.5 million of cash used in operating
activities partially offset by $2.6 million of proceeds from the
issuance of shares under its ATM program. We believe our cash and
investments balance is sufficient to fund operations into 2020.
Operating Expenses
Research and development expenses for the three
months ended March 31, 2019 were $14.8 million compared to $13.9
million for the three months ended March 31, 2018. Research and
development expenses for the three months ended March 31, 2019
included costs associated with the Company’s Phase 1a/1b clinical
trial for its lead capsid inhibitor (AB-506), pre-clinical studies
for its RNAi agent (AB-729), and characterization activities for
its HBV RNA Destabilizer (AB-452). General and Administrative
expenses for the three months ended March 31, 2019 were $4.4
million compared to $3.7 million for the three months ended March
31, 2018.
Equity investment loss
The Company recorded a loss of $4.7
million in the first quarter of 2019 for its proportionate
share of Genevant’s net loss, a company launched with Roivant
Sciences Ltd. There was no comparable amount for the first quarter
of 2018. Financial results of Genevant are recorded on a
one-quarter lag basis. The Company currently owns
approximately 40% of the common equity of Genevant as of March
31, 2019.
Net Loss
For the three months ended March 31, 2019, net
loss attributable to common shares was $26.0 million ($0.47 basic
and diluted loss per common share) as compared to $19.8 million
($0.36 basic and diluted loss per common share) for the three
months ended March 31, 2018. Net loss attributable to common shares
for the three months ended March 31, 2019 included $2.7 million of
non-cash expense for the accrual of coupon on its convertible
preferred shares. The increase in net loss is due primarily to the
equity investment loss in Genevant.
Outstanding Shares
The Company had approximately 55.7 million
common shares issued and outstanding as of March 31, 2019. In
addition, the Company had approximately 7.7 million options
outstanding and 1.164 million convertible preferred shares
outstanding, which (including the annual 8.75% coupon) will be
mandatorily convertible into approximately 23 million common shares
on October 18, 2021. Assuming the outstanding options and
convertible preferred shares were fully converted, the Company
would have had approximately 86 million common shares outstanding
as of March 31, 2019.
UNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF LOSS (in millions,
except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2019 |
2018 |
|
|
|
|
|
|
Total
revenue |
|
$ |
0.7 |
|
|
$ |
1.4 |
|
|
Operating expenses: |
|
|
|
|
Research and
development |
|
14.8 |
|
|
13.9 |
|
|
General and
administrative |
|
4.4 |
|
|
3.7 |
|
|
Depreciation
and amortization |
|
0.5 |
|
|
0.6 |
|
|
Site
consolidation |
|
0.1 |
|
|
1.6 |
|
|
Loss from
operations |
|
(19.1 |
) |
|
(18.4 |
) |
|
Other income (loss) |
|
|
|
|
|
Interest income
(expense), net |
|
0.6 |
|
|
0.7 |
|
|
Foreign exchange
gain (loss) |
|
— |
|
|
(0.5 |
) |
|
Equity investment
loss |
|
(4.7 |
) |
|
— |
|
|
Decrease (increase)
in fair value of contingent consideration |
|
(0.1 |
) |
|
0.8 |
|
|
Total other income |
|
(4.2 |
) |
|
1.0 |
|
|
Net
loss |
|
$ |
(23.3 |
) |
|
$ |
(17.4 |
) |
|
Accrual of coupon on
convertible preferred shares |
|
|
(2.7 |
) |
|
|
(2.3 |
) |
|
Net loss
attributable to common shares |
|
$ |
(26.0 |
) |
|
$ |
(19.8 |
) |
|
|
|
|
|
|
|
|
|
Loss per
share |
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.47 |
) |
|
$ |
(0.36 |
) |
|
|
|
|
|
|
|
|
|
Weighted average
number of shares |
|
|
|
|
|
|
|
Basic and diluted |
|
|
55,740,121 |
|
|
|
55,071,964 |
|
|
UNAUDITED CONDENSED CONSOLIDATED
BALANCE SHEETS(in millions) |
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2019 |
|
2018 |
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
84.0 |
|
|
$ |
36.9 |
|
|
Short-term
investments |
26.6 |
|
|
87.7 |
|
|
Accounts receivable and
other current assets |
1.8 |
|
|
4.6 |
|
|
Investment in
Genevant |
17.7 |
|
|
22.2 |
|
|
Property and equipment,
net |
9.7 |
|
|
10.2 |
|
|
Right of use asset |
3.1 |
|
|
— |
|
|
Intangible assets |
43.8 |
|
|
43.8 |
|
|
Goodwill |
22.5 |
|
|
22.5 |
|
|
Total
assets |
$ |
209.2 |
|
|
$ |
227.9 |
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities |
6.8 |
|
|
9.5 |
|
|
Site consolidation
accrual |
1.0 |
|
|
1.3 |
|
|
Liability-classified
options |
0.4 |
|
|
0.5 |
|
|
Lease liability,
current |
0.6 |
|
|
— |
|
|
Deferred rent and
inducements, non-current |
— |
|
|
0.6 |
|
|
Contingent
consideration |
3.2 |
|
|
3.1 |
|
|
Lease liability,
non-current |
3.3 |
|
|
— |
|
|
Deferred tax
liability |
12.7 |
|
|
12.7 |
|
|
Total stockholders’
equity |
181.2 |
|
|
200.2 |
|
|
Total liabilities
and stockholders’ equity |
$ |
209.2 |
|
|
$ |
227.9 |
|
|
UNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOW(in millions) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2019 |
2018 |
|
|
|
|
|
|
|
Net loss for the
period |
|
$ |
(23.3 |
) |
|
$ |
(17.4 |
) |
|
|
|
Net cash
used in operating activities |
|
(16.5 |
) |
|
(20.0 |
) |
|
|
|
Net cash
provided by (used in) investing activities |
|
61.0 |
|
|
(75.7 |
) |
|
|
|
Net cash
provided by financing activities |
|
2.5 |
|
|
54.4 |
|
|
|
|
Effect of
foreign exchange rate changeson cash & cash equivalents |
|
(0.0 |
) |
|
(0.5 |
) |
|
|
|
Net (decrease)
increase in cash, cash equivalents and restricted
investments |
|
$ |
47.0 |
|
|
$ |
(41.8 |
) |
|
|
|
Cash, cash equivalents and
restrictedinvestments, beginning of period |
|
37.0 |
|
|
54.3 |
|
|
|
|
Cash, cash
equivalents and restricted investments, end of
period |
|
$ |
84.0 |
|
|
$ |
12.5 |
|
|
|
|
Short-term
investments |
|
|
26.6 |
|
|
|
160.1 |
|
|
|
|
Total cash, cash
equivalents, restricted cash and short-term investments,
end of period |
|
$ |
110.6 |
|
|
$ |
172.6 |
|
|
|
|
Conference Call Today
Arbutus will hold a conference call and webcast
today, Monday, May 6, 2019 at 4:30 PM Eastern Time (1:30 PM Pacific
Time) to provide a corporate update. You can access a live webcast
of the call through the Investors section of Arbutus' website at
www.arbutusbio.com. Alternatively, you can dial (866) 393-1607 or
(914) 495-8556 and reference conference ID 9448718.
An archived webcast will be available on the
Arbutus website after the event. Alternatively, you may access a
replay of the conference call by calling 855) 859-2056 or (404)
537-3406, and reference conference ID 9448718.
About Arbutus
Arbutus Biopharma Corporation is a publicly
traded (Nasdaq: ABUS) biopharmaceutical company dedicated to
discovering, developing and commercializing a cure for patients
suffering from chronic Hepatitis B infection. Arbutus is developing
multiple drug candidates, each of which have the potential to
improve upon the standard of care and contribute to a curative
combination regimen. For more information, visit
www.arbutusbio.com.
Forward-Looking Statements and
Information
This press release contains forward-looking
statements within the meaning of the Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
and forward-looking information within the meaning of Canadian
securities laws (collectively, “forward-looking statements”).
Forward-looking statements in this press release include statements
about our belief that our pipeline of proprietary therapeutic
agents that target HBV replication and HBsAg expression could lead
to an HBV cure; our expectation for top-line safety and efficacy
results from an interim analysis of the initial Phase 1a/1b
clinical trial of AB-506 in July 2019 and our intention to
present more detailed information on the trial at an upcoming
scientific conference towards the end of 2019; our expectation to
make a decision regarding AB-452 clinical development in early
2020; our expectation to initiate a Phase 2a dose-finding and
long-term safety trial of AB-506 late in the second half of 2019;
the trajectory for inclusion of AB-506 in a multi-drug combination
regimen with AB-729 in 2020; our goal to have a second generation
candidate nominated by the end of 2019; our expectations regarding
the initiation, timing and completion of preclinical studies and
clinical trials; the sufficiency of our cash and cash equivalents
to extend into 2020; and the potential for our drug candidates to
improve upon the standard of care and contribute to a curative
combination regimen for chronic HBV.
With respect to the forward-looking statements
contained in this press release, Arbutus has made numerous
assumptions regarding, among other things: the timely receipt of
expected payments; the effectiveness and timeliness of preclinical
and clinical trials, and the usefulness of the data; the timeliness
of regulatory approvals; the continued demand for Arbutus’ assets;
and the stability of economic and market conditions. While Arbutus
considers these assumptions to be reasonable, these assumptions are
inherently subject to significant business, economic, competitive,
market and social uncertainties and contingencies.
Additionally, there are known and unknown risk
factors which could cause Arbutus' actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements contained herein. Known risk factors
include, among others: anticipated pre-clinical studies and
clinical trials may be more costly or take longer to complete than
anticipated, and may never be initiated or completed, or may not
generate results that warrant future development of the tested drug
candidate; Arbutus may not receive the necessary regulatory
approvals for the clinical development of Arbutus' products;
economic and market conditions may worsen; and market shifts may
require a change in strategic focus.
A more complete discussion of the risks and
uncertainties facing Arbutus appears in Arbutus' Annual Report on
Form 10-K and Arbutus' continuous disclosure filings, which are
available at www.sedar.com and at www.sec.gov. All forward-looking
statements herein are qualified in their entirety by this
cautionary statement, and Arbutus disclaims any obligation to
revise or update any such forward-looking statements or to publicly
announce the result of any revisions to any of the forward-looking
statements contained herein to reflect future results, events or
developments, except as required by law.
Contact Information
InvestorsMark J. MurrayPresident and CEOPhone:
604-419-3200Email: ir@arbutusbio.com
MediaPam Murphy Investor Relations Consultant
Phone: 604-419-3200 Email: ir@arbutusbio.com
Arbutus Biopharma (NASDAQ:ABUS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Arbutus Biopharma (NASDAQ:ABUS)
Historical Stock Chart
From Apr 2023 to Apr 2024